FDA announces new draft guidances on medical product communications- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Today, FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing.

For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.

The guidances and information on the comment period for the off-label public hearing can be found at:  

• Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers

• Medical Product Communications that are Consistent with the FDA-required Labeling – Questions and Answers

• Reopening Public Comment Period for Part 15 Hearing on Manufacturer Communications About Unapproved Uses of Approved/Cleared Medical Products